HIMSS Immunization Integration Program CDC Test Plan v10.5

The practice site for the scenario is Shoreline Pediatrics. The EHR vendor loads demographic data and clinical history for Juana Mariana Vazquez. The data includes immunizations provided by the practice.

The vendor also enters:

-Two vaccines administered at other sites

1. an influenza vaccine given at a local pharmacy

2. an inactivated polio vaccine given elsewhere and not reported to the registry - the history includes an adverse reaction (febrile seizure) 8 hours after the vaccine was administered

- Adverse reaction to inactivated polio vaccine (febrile seizure) and the date and source of information

NOTE: the historical vaccines will be imported during the Registry query (e.g. from another practice).

Set-up step evaluating EHR functions for capturing and storing patient pediatric demographic data, historical immunizations, and clinical conditions. There is no transaction associated with this test step.

No Pre-Condition

The EMR has recorded all of the pediatric demographic data, historical immunizations, and clinical conditions in the record created for Juana Mariana Vazquez using the test data provided.

Register New Patients: The EHR or other clinical software system must allow a user to enter distinguishing information about patients so that providers can uniquely identify patients who have similar sounding names or other similar identifying information. For example, twins living in the same household will have similar dates of birth, addresses, and may have similar names. The EHR or other clinical software system must be able to store information to successfully match with patients in immunization registries, if the information is available. Specific to immunization registries, that information includes the mother's maiden name, whether the patient was part of a multiple birth, and the birth order (i.e., ordinal number of birth, first, second, etc.). This information allows the provider to correctly identify the patient and also helps ensure a match when the EHR sends the patient's information to external systems such as an immunization registry.

Record Past Immunizations: The EHR or other clinical software system allows providers to enter information about immunizations given elsewhere (e.g., by another doctor, at a public health clinic, pharmacy, etc.) with incomplete details.

Request/Receive Patient Immunization Data and Identify Source: The EHR stores immunization history accepted electronically from other sources (such as a public health immunization registry consistent with HL7 version 2.5.1, Implementation Guide for Immunization Messaging Release 1.5) or communicated by the patient and manually entered by the clinician. When viewing such information, the provider can determine which immunizations were administered by the practice, which were entered historically as patient-reported, and which were accepted electronically from the public health registry.

Data Quality Checks: The EHR or other clinical software system Integrates additional data quality checks into IIP Testing and Recognition to improve data quality and reduce rejections.

Note: The EHR or other clinical software system prevents specific data issues which would potentially result in IIS errors as defined by the AIRA Error Codes. This supports reducing data quality issues that could trigger the following AIRA-defined Error Codes:

• 2104 : Indicates that a historical dose is being reported for the current date.
• 2204 : Indicates that the administration being reported occurred too far in the past.

Supporting data for:

Compare Public Health Immunization Registry (IIS) Immunization History to EHR Immunization History: The public health immunization registry has returned the requested immunization history for a patient (Return Evaluated Immunization History and Forecast (Z42) – HL7 Version 2.5.1 Implementation Guide for Immunization Messaging Release 1.5). The EHR is able to display the evaluated immunization history received from the registry as well as the immunization history already present in the EHR so that a user can compare them. The EHR provides a way for the provider to view both histories, determine what is different (if anything), and update the existing EHR immunization history with new information from the public health registry if they choose to do so. The system must store the new information as structured data as part of the patient's local immunization history and include the time of the update and the source of the new information.

Identify Adverse Event: The EHR or other clinical software system enables capture of structured data regarding adverse events.

Evaluation criteria is defined within each test step.

No Note

The EHR vendor loads demographic data for Juana Mariana Vazquez.

Set-up step evaluating EHR functions for capturing and storing patient pediatric demographic data. There is no transaction associated with this test step.

No Pre-Condition

The EHR has recorded all of the pediatric demographic in the record created for Juana Mariana Vazquez.

Register New Patients: The EHR or other clinical software system must allow a user to enter distinguishing information about patients so that providers can uniquely identify patients who have similar sounding names or other similar identifying information. For example, twins living in the same household will have similar dates of birth, addresses, and may have similar names. The EHR or other clinical software system must be able to store information to successfully match with patients in immunization registries, if the information is available. Specific to immunization registries, that information includes the mother's maiden name, whether the patient was part of a multiple birth, and the birth order (i.e., ordinal number of birth, first, second, etc.). This information allows the provider to correctly identify the patient and also helps ensure a match when the EHR sends the patient's information to external systems such as an immunization registry.

Evaluation Criteria: Vendor successfully records all demographic data provided, and in particular (mother's maiden name, multiple birth, birth order), with all required attributes indicated by [Y]. The code values are not expected to be displayed to the user, but it is expected that the value selected has the identified meaning, and it is expected that the system will use the specified coded value when the attribute is conveyed in later transaction messages.

For systems that document vaccine program eligibility at the patient level: VFC Eligible

To minimize data entry, the ADT A04 message below the data table may be used to automate data entry. If this option is used, the proctor will review the ability of the system to record, modify, and store these attributes.

ADT A04 Message:

MSH|^~\&|Test EHR Application|X68||NIST Test Iz Reg|20221031082240-0500||ADT^A04^ADT_A01|NIST-IZ-001.00|P|2.5.1|||ER|AL|||||

EVN|A04|202210310822|202210310822|01||202210310822

PID|1||123456^^^MYEHR^MR~987633^^^MYIIS^SR||Vazquez^Juana^Mariana^^^^L|Acosta^Maria^Merida^^^^M|201711011105|F||2106-3^White^CDCREC|4345 Standish Way^^Stamford^CT^06903^USA^L||^PRN^CP^^1^203^5551212~^NET^^jmg@gmail.com||eng^English^ISO639|||||||2135-2^Hispanic or Latino^CDCREC||N

PD1|||||||||||02^Reminder/Recall - any method^HL70215|N|20171101|||A|20171101|20171101

NK1|1|Vazquez^Joanna^Merida^^^^L|GRP^Grandparent^HL70063|4345 Standish Way^^Stamford^CT^06903^^L|^PRN^CP^^1^203^5551212~^NET^^jmg@gmail.com

PV1||O|||||^Smith^Frank^^^^^^^L^^^^^^^^^^^MD|^Smith^Frank^^^^^^^L^^^^^^^^^^^MD| ||||||||||||||||||||||||||||||SP^Shoreline Pediatrics^HL70362||||||

Publicity Code is included in order to support documentation of communication method for the TestCaseGroup:Cohort Report. If the EHR does not support this attribute, the result for this step may indicate pass, but the lack of support should be documented as a notable exception.

The date/time of birth for the twins includes birth time. This aids in distinguishing the birth order for multiple births. Since this patient is not a multiple birth, the vendor can pass with notable exception if the birth date/time does not include precision of birth time. The notable exception should document the lack of support for birth time.

While the PID indicates that it is Vendor Supplied, the ID returned from the registry query is: 123456^^^MYEHR^MR~987633^^^MYIIS^SR. The IIS will not know the PID of the local system, and there is no context-based validation checking for the PID.

Registry status of' 'Active' is required when sending a VXU to the IIS which will be done for this patient.

Manual entry of one of the patient demographics and clinical history will be required (or reviewed) to ensure that entry of the required fields is possible.

The EHR vendor loads immunization history data from the local practice for Juana Mariana Vazquez. This includes an MMR dose that was given too early. This MMR dose serves to seed checking for dose given too early in TestCaseGroup: Juana Mariana Vazquez Visit, TestCase: Query the Registry for Juana Mariana Vazquez, TestStep: Mark first MMR Dose as Invalid.

No Comments

The EHR has recorded all of the pediatric demographic data in the record created for Juana Mariana Vazquez.

The EHR has recorded all of the pediatric demographic data in the record created for Juana Mariana Vazquez.

Record Past Immunizations: The EHR or other clinical software system allows providers to enter information about immunizations given elsewhere (e.g., by another doctor, at a public health clinic, pharmacy, etc.) with incomplete details.

Request/Receive Patient Immunization Data and Identify Source: The EHR stores immunization history accepted electronically from other sources (such as a public health immunization registry consistent with HL7 version 2.5.1, Implementation Guide for Immunization Messaging Release 1.5) or communicated by the patient and manually entered by the clinician. When viewing such information, the provider can determine which immunizations were administered by the practice, which were entered historically as patient-reported, and which were accepted electronically from the public health registry.

Supporting data for:

Compare Public Health Immunization Registry (IIS) Immunization History to EHR Immunization History: The public health immunization registry has returned the requested immunization history for a patient (Return Evaluated Immunization History and Forecast (Z42) – HL7 Version 2.5.1 Implementation Guide for Immunization Messaging Release 1.5). The EHR is able to display the evaluated immunization history received from the registry as well as the immunization history already present in the EHR so that a user can compare them. The EHR provides a way for the provider to view both histories, determine what is different (if anything), and update the existing EHR immunization history with new information from the public health registry if they choose to do so. The system must store the new information as structured data as part of the patient's local immunization history and include the time of the update and the source of the new information.

Receive Dose Not Indicated Alert for Single Vaccine Order: The EHR or other clinical software system notifies the provider in instances when there are single or combination vaccine orders that are inconsistent with the expected timing intervals included in the vaccine forecast. Inconsistencies include suggestion of different date(s) for ordering the vaccine(s) or indication the vaccine(s) is/are no longer required.

The MMR dose serves to seed checking for dose given too early in TestCaseGroup: Juana Mariana Vazquez Visit, TestCase: Query the Registry for Juana Mariana Vazquez, TestStep: Mark first MMR Dose as Invalid.

The EHR does not need to specify a 'new immunization', as long as there is a way to indicate that it is a new immunization within the EHR, this is acceptable (e.g. the default interpretation of the data entry is that it is a new immunization and not historical).

The EHR vendor loads immunization history data from another practice into the record for Juana Mariana Vazquez.

No Comments

The EHR has recorded all of the pediatric demographic data in the record created for Juana Mariana Vazquez.

The immunization history from another practice is loaded into the record created for Juana Mariana Vazquez.

Record Past Immunizations: The EHR or other clinical software system allows providers to enter information about immunizations given elsewhere (e.g., by another doctor, at a public health clinic, pharmacy, etc.) with incomplete details.

Request/Receive Patient Immunization Data and Identify Source: The EHR stores immunization history accepted electronically from other sources (such as a public health immunization registry consistent with HL7 version 2.5.1, Implementation Guide for Immunization Messaging Release 1.5) or communicated by the patient and manually entered by the clinician. When viewing such information, the provider can determine which immunizations were administered by the practice, which were entered manually as patient-reported, and which were accepted electronically from the public health registry.

Supporting data for:

Compare Public Health Immunization Registry (IIS) Immunization History to EHR Immunization History: The public health immunization registry has returned the requested immunization history for a patient (Return Evaluated Immunization History and Forecast (Z42) – HL7 Version 2.5.1 Implementation Guide for Immunization Messaging Release 1.5). The EHR is able to display the evaluated immunization history received from the registry as well as the immunization history already present in the EHR so that a user can compare them. The EHR provides a way for the provider to view both histories, determine what is different (if anything), and update the existing EHR immunization history with new information from the public health registry if they choose to do so. The system must store the new information as structured data as part of the patient's local immunization history and include the time of the update and the source of the new information.

Evaluation Criteria: Vendor successfully records all immunization history data from another practice as provided, with all required attributes indicated by [Y]:

No Note

The provider attempts to enter immunization data with a data entry error and is alerted that the date identified is too long ago, in this case, before birth. 

This situation may arise where the vaccination date on the materials provided was misread.

The EHR has recorded all of the pediatric demographic data in the record created for Juana Mariana Vazquez.

The provider has been alerted that the vaccination date was too long ago.

Data Quality Checks: The EHR or other clinical software integrates additional data quality checks into IIP Testing and Recognition to improve data quality and reduce rejections.

Note: The EHR or other clinical software system prevents specific data issues which would potentially result in IIS errors as defined by the AIRA Error Codes. This supports reducing data quality issues that could trigger the following AIRA-defined Error Codes:

2204: Indicates that the administration being reported occurred too far in the past.

Evaluation Criteria: During the course of data entry for information below, the EHR triggers the following data quality issues:

1. Triggers error that the vaccination date entered was too long ago (2204)

Full vaccination details are provided, but only the minimum data entry necessary to trigger the alert is required for this test step as determined by the vendor. This same information with the correct date will be entered in later in this test case.

The provider attempts to enter historical immunization for the current date and is alerted that of the possible data quality error.

No comment.

The EHR has recorded all of the pediatric demographic data in the record created for Juana Mariana Vazquez.

The provider has been alerted that the vaccination date for the historical administration was documented as the current date.

Data Quality Checks: The EHR or other clinical software integrates additional data quality checks into IIP Testing and Recognition to improve data quality and reduce rejections.

Note: The EHR or other clinical software system prevents specific data issues which would potentially result in IIS errors as defined by the AIRA Error Codes. This supports reducing data quality issues that could trigger the following AIRA-defined Error Codes:

  -  2104: Indicates that a historical dose is being reported for the current date.

Evaluation Criteria: Vendor alerts provider that the historical vaccination date entered is the current date:

Full vaccination details are provided, but only the minimum data entry necessary to trigger the alert is required for this test step as determined by the vendor. This same information with the correct date will be entered in later in this test case.

The provider enters immunization data from a pharmacy as reported by the parent for Juana Mariana Vazquez.

No Comments

The EHR has recorded all of the pediatric demographic data in the record created for Juana Mariana Vazquez.

The immunization history from the pharmacy as reported by the parent is loaded into the record created for Juana Mariana Vazquez.

Record Past Immunizations: The EHR or other clinical software system allows providers to enter information about immunizations given elsewhere (e.g., by another doctor, at a public health clinic, pharmacy, etc.) with incomplete details.

Request/Receive Patient Immunization Data and Identify Source: The EHR stores immunization history accepted electronically from other sources (such as a public health immunization registry consistent with HL7 version 2.5.1, Implementation Guide for Immunization Messaging Release 1.5) or communicated by the patient and manually entered by the clinician. When viewing such information, the provider can determine which immunizations were administered by the practice, which were entered historically as patient-reported, and which were accepted electronically from the public health registry.

Supporting data for:

Compare Public Health Immunization Registry (IIS) Immunization History to EHR Immunization History: The public health immunization registry has returned the requested immunization history for a patient (Return Evaluated Immunization History and Forecast (Z42) – HL7 Version 2.5.1 Implementation Guide for Immunization Messaging Release 1.5). The EHR is able to display the evaluated immunization history received from the registry as well as the immunization history already present in the EHR so that a user can compare them. The EHR provides a way for the provider to view both histories, determine what is different (if anything), and update the existing EHR immunization history with new information from the public health registry if they choose to do so. The system must store the new information as structured data as part of the patient's local immunization history and include the time of the update and the source of the new information.

Evaluation Criteria: Vendor successfully records all immunization history data from the pharmacy as provided by the parent with all required attributes indicated by [Y]:

No Note

The practice site for the scenario is Shoreline Pediatrics. The EHR vendor loads demographic data and clinical history for Juan Marcel Marina. The data includes a clinical history of varicella, and serological evidence of Hepatitis A immunity.

Set-up step evaluating EHR functions for capturing and storing patient pediatric demographic data, historical immunizations, and clinical conditions. There is no transaction associated with this test step.

No Pre-Condition

The EHR has recorded all of the pediatric demographic data, historical immunizations, and clinical conditions in the record created for Juan Marcel Marina using the test data provided.

Register New Patients: The EHR or other clinical software system must allow a user to enter distinguishing information about patients so that providers can uniquely identify patients who have similar sounding names or other similar identifying information. For example, twins living in the same household will have similar dates of birth, addresses, and may have similar names. The EHR or other clinical software system must be able to store information to successfully match with patients in immunization registries, if the information is available. Specific to immunization registries, that information includes the mother's maiden name, whether the patient was part of a multiple birth, and the birth order (i.e., ordinal number of birth, first, second, etc.). This information allows the provider to correctly identify the patient and also helps ensure a match when the EHR sends the patient's information to external systems such as an immunization registry.

Supporting data for:

Modify Antigen Recommendations Based on Active Diagnoses: The EHR or other clinical software system notifies the provider of any conflicts between recommended vaccines in the updated forecast and the patient's current or historical diagnoses.

Evaluation criteria is defined within each test step.

No Note

The EHR vendor loads demographic data for Juan Marcel Marina.

Set-up step evaluating EHR functions for capturing and storing patient pediatric demographic data. There is no transaction associated with this test step.

No Pre-Condition

The EHR has recorded all of the pediatric demographic in the record created for Juan Marcel Marina.

Register New Patients: The EHR or other clinical software system must allow a user to enter distinguishing information about patients so that providers can uniquely identify patients who have similar sounding names or other similar identifying information. For example, twins living in the same household will have similar dates of birth, addresses, and may have similar names. The EHR or other clinical software system must be able to store information to successfully match with patients in immunization registries, if the information is available. Specific to immunization registries, that information includes the mother's maiden name, whether the patient was part of a multiple birth, and the birth order (i.e., ordinal number of birth, first, second, etc.). This information allows the provider to correctly identify the patient and also helps ensure a match when the EHR sends the patient's information to external systems such as an immunization registry.

Evaluation Criteria: Vendor successfully records all demographic data provided, and in particular (Mother's maiden name, multiple birth, birth order), with all required attributes indicated by [Y]. The coded values are not expected to be displayed to the user, but it is expected that the value selected has the identified meaning, and it is expected that the system will use the coded value when the attribute is conveyed in later transactions:

For systems that document vaccine program eligibility at the patient level: Not VFC Eligible

To minimize data entry, the ADT A04 message below the data table may be used to automate data entry. If this option is used, the proctor will review the ability of the system to record, modify, and store these attributes.

ADT A04 Message:

MSH|^~\&|Test EHR Application|X68||NIST Test Iz Reg|20221031082240-0500||ADT^A04^ADT_A01|NIST-IZ-001.00|P|2.5.1|||||||||

PID|1||123456^^^MYEHR^MR~987633^^^MYIIS^SR||Marina^Juan^Marcel^^^^L|Morales^Anita^Francesca^^^^M|202103041100|M||2106-3^White^CDCREC|4623 Standish Way^^Stamford^CT^06903^USA^L||^PRN^CP^^1^203^5551213||eng^English^ISO639|||||||2135-2^Hispanic or Latino^CDCREC||N

PD1|||||||||||03^Reminder/recall – no calls^HL70215|N|20210304|||A|20210304|20210304

NK1|1|Marina^Manuel^Marcel^^^^L|FTH^Father^HL70063|4623 Standish Way^^Stamford^CT^06903^^L|^PRN^CP^^1^203^5551213

PV1||O|||||^Smith^Frank^^^^^^^L^^^^^^^^^^^MD|^Smith^Frank^^^^^^^L^^^^^^^^^^^MD| ||||||||||||||||||||||||||||||SP^Shoreline Pediatrics^HL70362||||||

OBX|1|CE|51913-2^Hepatitis A virus IgG+IgM Ab [Presence] in Serum ^LN|1|260373001^Detected^SCT||||||F|||20220115

DG1|2|||38907003^Varicella (disorder)^SCT|20220316|F|

Publicity Code is included in order to support documentation of communication method for the TestCaseGroup:Cohort Report. If the EHR does not support this attribute, the result for this step may indicate pass, but the lack of support should be documented as a notable exception.

The date/time of birth for the twins includes birth time. This aids in distinguishing the birth order for multiple births. Since this patient is not a multiple birth, the vendor can pass with notable exception if the birth date/time does not include precision of birth time. The notable exception should document the lack of support for birth time.

While the PID indicates that it is Vendor Supplied, the ID returned from the registry query is: 123456^^^MYEHR^MR~987633^^^MYIIS^SR. The IIS will not know the PID of the local system, and there is no context-based validation checking for the PID.

Registry status of' 'Active' is required when sending a VXU to the IIS which will be done for this patient.

Manual entry of one of the patient demographics and clinical history will be required (or reviewed) to ensure that entry of the required fields is possible.

The clinical history of varicella (chickenpox) is documented in the record created for Juan Marcel Marina.

The lab tests show serologic immunity to Hep A and a finding is added indicating Hepatitis A Immune.

No Comments

The EHR has recorded all of the pediatric demographic in the record created for Juan Marcel Marina.

The clinical history of the Varicella is documented in the record created for Juan Marcel Marina.

The serologic immunity (Hepatitis A virus IgG+IgM Ab [Presence] in Serum) - result positive and a finding of Hepatitis A Immune is documented in the record for Juan Marcel Marina.

Supporting data for:

Modify Antigen Recommendations Based on Active Diagnoses: The EHR or other clinical software system notifies the provider of any conflicts between recommended vaccines in the updated forecast and the patient's current or historical diagnoses.

Note: In this case, the vaccine is not recommended due to the history of the vaccine preventable condition (Varicella).

Evaluation Criteria: Vendor successfully records all clinical history data provided with all required attributes indicated by [Y]. The coded values are not expected to be displayed to the user, but it is expected that the value selected has the identified meaning, and it is expected that the system will use the coded value when the attribute is conveyed in later transactions:

Serologic Evidence of Immunity to Hepatitis A is documented in the record:

Lab Result and Finding (01/15/2022):

LOINC 51913-2 Hepatitis A virus IgG+IgM Ab [Presence] in Serum - result positive.

Finding of Hepatitis A Immunity is recorded (SNOMED 278971009 Hepatitis A Immune (finding)).

To minimize data entry, the ADT A04 message provided in Step 1 for this patient: Enter Initial Demographic Data for New Patient Juan Marcel Marina, included this clinical data table and may be used to automate data entry for this step. If this option is used, the proctor will review the ability of the system to record, modify, and store these attributes.

Manual entry of one of the patient demographics and clinical history will be required (or reviewed) to ensure that entry of the required fields is possible.

The practice site for the scenario is Shoreline Pediatrics. The EHR vendor loads demographic data and clinical history for twin Juana Mariela Gonzales.

Set-up step evaluating EHR functions for capturing and storing patient pediatric demographic data, historical immunizations, and clinical conditions. There is no transaction associated with this test step.

No Pre-Condition

The EHR has recorded all of the pediatric demographic data, historical immunizations, and clinical conditions in the record created for Juana Mariela Gonzales using the test data provided.

Register New Patients: The EHR or other clinical software system must allow a user to enter distinguishing information about patients so that providers can uniquely identify patients who have similar sounding names or other similar identifying information. For example, twins living in the same household will have similar dates of birth, addresses, and may have similar names. The EHR or other clinical software system must be able to store information to successfully match with patients in immunization registries, if the information is available. Specific to immunization registries, that information includes the mother's maiden name, whether the patient was part of a multiple birth, and the birth order (i.e., ordinal number of birth, first, second, etc.). This information allows the provider to correctly identify the patient and also helps ensure a match when the EHR sends the patient's information to external systems such as an immunization registry.

Evaluation criteria is defined within each test step.

No Note

The EHR vendor loads demographic data for Juana Mariela Gonzales.

Set-up step evaluating EHR functions for capturing and storing patient pediatric demographic data. There is no transaction associated with this test step.

No Pre-Condition

The EHR has recorded all of the pediatric demographic data in the record created for Juana Mariela Gonzales.

Register New Patients: The EHR or other clinical software system must allow a user to enter distinguishing information about patients so that providers can uniquely identify patients who have similar sounding names or other similar identifying information. For example, twins living in the same household will have similar dates of birth, addresses, and may have similar names. The EHR or other clinical software system must be able to store information to successfully match with patients in immunization registries, if the information is available. Specific to immunization registries, that information includes the mother's maiden name, whether the patient was part of a multiple birth, and the birth order (i.e., ordinal number of birth, first, second, etc.). This information allows the provider to correctly identify the patient and also helps ensure a match when the EHR sends the patient's information to external systems such as an immunization registry.

Evaluation Criteria: Vendor successfully records all demographic data provided, and in particular (Mother's maiden name, multiple birth, birth order), with all required attributes indicated by [Y]. The coded values are not expected to be displayed to the user, but it is expected that the value selected has the identified meaning, and it is expected that the system will use the coded value when the attribute is conveyed in later transactions:

For systems that document vaccine program eligibility at the patient level: not VFC Eligible

To minimize data entry, the ADT A04 message below the data table may be used to automate data entry. If this option is used, the proctor will review the ability of the system to record, modify, and store these attributes.

ADT A04 Message:

MSH|^~\&|Test EHR Application|X68||NIST Test Iz Reg|20221031082240-0500||ADT^A04^ADT_A01|NIST-IZ-001.00|P|2.5.1|||||||||

PID|1||123456^^^MYEHR^MR~987633^^^MYIIS^SR||Gonzales^Juana^Mariela^^^^L|Morales^Joanna^Elena^^^^M|202210011100|F||2106-3^White^CDCREC|3321 Standish Way^Stamford^CT^06903^USA^L||^PRN^CP^^1^203^5551214||eng^English^ISO639|||||||2135-2^Hispanic or Latino^CDCREC||Y|1

PD1|||||||||||03^Reminder/recall – no calls^HL70215|N|20221001|||A|20221001|20221001

NK1|1|Gonzales^Joanna^Elena^^^^L|MTH^Mother^HL70063|3321 Standish Way^^Stamford^CT^06903^^L|^PRN^CP^^1^203^5551214

PV1||O|||||^Smith^Frank^^^^^^^L^^^^^^^^^^^MD|^Smith^Frank^^^^^^^L^^^^^^^^^^^MD|||||||||||||||||||||||||||||||SP^Shoreline Pediatrics^HL70362||||||

Publicity Code is included in order to support documentation of communication method for the TestCaseGroup:Cohort Report. If the EHR does not support this attribute, the result for this step may indicate pass, but the lack of support should be documented as a notable exception.

The date/time of birth for the twins includes birth time. This aids in distinguishing the birth order of the twins, but as long as birth order is supplied, the vendor can pass with notable exception if the birth date/time does not include precision of birth time. The notable exception should document the lack of support for birth time.

While the PID indicates that it is Vendor Supplied, the ID returned from the registry query is: 123456^^^MYEHR^MR~987633^^^MYIIS^SR. The IIS will not know the PID of the local system, and there is no context-based validation checking for the PID.

Protection Indicator Effective Date may use current date if constrained by EHR workflow.

Registry status of' 'Active' is required when sending a VXU to the IIS which will be done for this patient.

Manual entry of one of the patient demographics and clinical history will be required (or reviewed) to ensure that entry of the required fields is possible.

The practice site for the scenario is Shoreline Pediatrics. The EHR vendor loads demographic data and clinical history for twin Juana Maria Gonzales.

Set-up step evaluating EHR functions for capturing and storing patient pediatric demographic data, historical immunizations, and clinical conditions. There is no transaction associated with this test step.

No Pre-Condition

The EHR has recorded all of the pediatric demographic data, historical immunizations, and clinical conditions in the record created for Juana Maria Gonzales using the test data provided.

Register New Patients: The EHR or other clinical software system must allow a user to enter distinguishing information about patients so that providers can uniquely identify patients who have similar sounding names or other similar identifying information. For example, twins living in the same household will have similar dates of birth, addresses, and may have similar names. The EHR or other clinical software system must be able to store information to successfully match with patients in immunization registries, if the information is available. Specific to immunization registries, that information includes the mother's maiden name, whether the patient was part of a multiple birth, and the birth order (i.e., ordinal number of birth, first, second, etc.). This information allows the provider to correctly identify the patient and also helps ensure a match when the EHR sends the patient's information to external systems such as an immunization registry.

Evaluation criteria is defined within each test step.

No Note

The EHR vendor loads demographic data for Juana Maria Gonzales.

Set-up step evaluating EHR functions for capturing and storing patient pediatric demographic data. There is no transaction associated with this test step.

No Pre-Condition

The EHR has recorded all of the pediatric demographic data in the record created for Juana Maria Gonzales.

Register New Patients: The EHR or other clinical software system must allow a user to enter distinguishing information about patients so that providers can uniquely identify patients who have similar sounding names or other similar identifying information. For example, twins living in the same household will have similar dates of birth, addresses, and may have similar names. The EHR or other clinical software system must be able to store information to successfully match with patients in immunization registries, if the information is available. Specific to immunization registries, that information includes the mother's maiden name, whether the patient was part of a multiple birth, and the birth order (i.e., ordinal number of birth, first, second, etc.). This information allows the provider to correctly identify the patient and also helps ensure a match when the EHR sends the patient's information to external systems such as an immunization registry.

Evaluation Criteria: Vendor successfully records all demographic data provided, and in particular (Mother's maiden name, multiple birth, birth order), with all required attributes indicated by [Y]. The coded values are not expected to be displayed to the user, but it is expected that the value selected has the identified meaning, and it is expected that the system will use the coded value when the attribute is conveyed in later transactions:

For systems that document vaccine program eligibility at the patient level: Not VFC Eligible

To minimize data entry, the ADT A04 message below the data table may be used to automate data entry. If this option is used, the proctor will review the ability of the system to record, modify, and store these attributes.

ADT A04 Message:

MSH|^~\&|Test EHR Application|X68||NIST Test Iz Reg|20221031082240-0500||ADT^A04^ADT_A01|NIST-IZ-001.00|P|2.5.1|||||||||

PID|1||123456^^^MYEHR^MR~987633^^^MYIIS^SR||Gonzales^Juana^Maria^^^^L|Morales^Joanna^Elena^^^^M|202210011115|F||2106-3^White^CDCREC|3321 Standish Way^^Stamford^CT^06903^USA^L||^PRN^CP^^1^203^5551214||eng^English^ISO639|||||||2135-2^Hispanic or Latino^CDCREC||Y|2

PD1|||||||||||03^Reminder/recall – no calls^HL70215|Y|20221001|||A|20221001|20221001

NK1|1|Gonzales^Joanna^Elena^^^^L|MTH^Mother^HL70063|3321 Standish Way^^Stamford^CT^06903^^L|^PRN^CP^^1^203^5551214

PV1||O|||||^Smith^Frank^^^^^^^L^^^^^^^^^^^MD|^Smith^Frank^^^^^^^L^^^^^^^^^^^MD|||||||||||||||||||||||||||||||SP^Shoreline Pediatrics^HL70362||||||

Publicity Code is included in order to support documentation of communication method for the TestCaseGroup:Cohort Report. If the EHR does not support this attribute, the result for this step may indicate pass, but the lack of support should be documented as a notable exception.

The date/time of birth for the twins includes birth time. This aids in distinguishing the birth order of the twins, but as long as birth order is supplied, the vendor can pass with notable exception if the birth date/time does not include precision of birth time. The notable exception should document the lack of support for birth time.

While the PID indicates that it is Vendor Supplied, the ID returned from the registry query is: 123456^^^MYEHR^MR~987633^^^MYIIS^SR. The IIS will not know the PID of the local system, and there is no context-based validation checking for the PID.

Protection Indicator Effective Date may use current date if constrained by EHR workflow.

Registry status of' 'Active' is required when sending a VXU to the IIS which will be done for this patient.

Manual entry of one of the patient demographics and clinical history will be required (or reviewed) to ensure that entry of the required fields is possible.

The practice site for the scenario is Metro Primary Care. The EHR vendor loads demographic data and clinical history for Adult Anita Francesca Marina.

Set-up step evaluating EHR functions for capturing and storing patient adult demographic data, historical immunizations, and clinical conditions. There is no transaction associated with this test step.

No Pre-Condition

The EHR has recorded all of the adult demographic data, historical immunizations, and clinical conditions in the record created for Anita Francesca Marina using the test data provided.

Register New Patients: The EHR or other clinical software system must allow a user to enter distinguishing information about patients so that providers can uniquely identify patients who have similar sounding names or other similar identifying information. For example, twins living in the same household will have similar dates of birth, addresses, and may have similar names. The EHR or other clinical software system must be able to store information to successfully match with patients in immunization registries, if the information is available. Specific to immunization registries, that information includes the mother's maiden name, whether the patient was part of a multiple birth, and the birth order (i.e., ordinal number of birth, first, second, etc.). This information allows the provider to correctly identify the patient and also helps ensure a match when the EHR sends the patient's information to external systems such as an immunization registry.

Provide Access to Update Immunization Information: The patient is able to add or request an update to immunization information for review by the provider.

Review Patient-Provided Immunization Information: The EHR or other clinical software system provides a mechanism for the provider to review patient-generated immunization data. It also provides a mechanism for the provider to update or annotate the immunization history, indicating the source of the information.

Request/Receive Patient Immunization Data and Identify Source: The EHR stores immunization history accepted electronically from other sources (such as a public health immunization registry consistent with HL7 version 2.5.1, Implementation Guide for Immunization Messaging Release 1.5) or communicated by the patient and manually entered by the clinician. When viewing such information, the provider can determine which immunizations were administered by the practice, which were entered historically as patient-reported, and which were accepted electronically from the public health registry.

Data Quality Checks: The EHR or other clinical software integrates additional data quality checks into IIP Testing and Recognition to improve data quality and reduce rejections.

   Note: The EHR or other clinical software system prevents specific data issues which would potentially result in IIS errors as defined by the AIRA Error Codes. This supports reducing data quality issues that could trigger the following AIRA-defined Error Codes:

  - 2002 : Indicates that the date of birth messaged in PID-7 is after the date of death messaged in PID-29.

  - 2100  : Indicates that any date field is in the future. Specific errors for date transmitted in an OBX are also provided.

  - 2202 : Indicates individual components of the address are valid, but overall, the address is invalid (conflict between elements, non-existent address, etc)

  - 2007: Indicates a conflict between PID-29 and PID-30 or between PD1-16 and either PID field. In other words, one element indicates the patient is deceased and another element indicates the patient is not deceased.

  - 2306 : Indicates that the patient found is too old.

Supporting data for:

Compare Public Health Immunization Registry (IIS) Immunization History to EHR Immunization History: The public health immunization registry has returned the requested immunization history for a patient (Return Evaluated Immunization History and Forecast (Z42) – HL7 Version 2.5.1 Implementation Guide for Immunization Messaging Release 1.5). The EHR is able to display the evaluated immunization history received from the registry as well as the immunization history already present in the EHR so that a user can compare them. The EHR provides a way for the provider to view both histories, determine what is different (if anything), and update the existing EHR immunization history with new information from the public health registry if they choose to do so. The system must store the new information as structured data as part of the patient's local immunization history and include the time of the update and the source of the new information.

Evaluation criteria is defined within each test step.

No Note

The EHR vendor attempts to enter demographic data for new adult patient Anita Francesca Marina. These data quality checks primarily relate to improving patient matching information that will be included when submitting data to the immunization registry or when querying the immunization registry.

Evaluates EHR functions for verifying data quality of demographic data used for patient matching. There is no transaction associated with this test step.

No Pre-Condition

The EHR has alerted the provider for each of the data quality checks verified for Anita Francesca Marina.

Data Quality Checks: The EHR or other clinical software integrates additional data quality checks into IIP Testing and Recognition to improve data quality and reduce rejections.

Note: The EHR or other clinical software system prevents specific data issues which would potentially result in IIS errors as defined by the AIRA Error Codes. This supports reducing data quality issues that could trigger the following AIRA-defined Error Codes:

  - 2002 : Indicates that the date of birth messaged in PID-7 is after the date of death messaged in PID-29.

  -  2100  : Indicates that any date field is in the future. Specific errors for date transmitted in an OBX are also provided.

  - 2202 : Indicates individual components of the address are valid, but overall, the address is invalid (conflict between elements, non-existent address, etc)

  - 2007: Indicates a conflict between PID-29 and PID-30 or between PD1-16 and either PID field. In other words, one element indicates the patient is deceased and another element indicates the patient is not deceased.

  - 2306 : Indicates that the patient found is too old.

Evaluation Criteria: During the course of data entry for information below, the EHR triggers the following data quality issues:

1. Triggers Error that patient is too old (2306)
2. Triggers error indicating, conflict: one element indicates the patient is deceased and another element indicates the patient is not deceased. (2207)
3. Triggers Error that the birth date is after the death date (2002)
4. Triggers conflict in address (Zip inconsistent with city and state) (2202)

The full demographic details are provided here to facilitate the documentation constraints and/or screens that may be required by the vendor in order to attempt to document the data of interest, but these are not verified until the next step. 

The Anita Francesca email supplied should be provided by the test proctor so they can receive the patient notifications. For the purpose of internal Vendor testing they can use their own emails.

Registry status of' 'Active' is required when sending a VXU to the IIS which will be done for this patient.

Manual entry of one of the patient demographics and clinical history will be required (or reviewed) to ensure that entry of the required fields is possible.

The EHR vendor loads demographic and social history data for Anita Francesca Marina.

Set-up step evaluating EHR functions for capturing and storing adult demographic data and social history data supporting immunization recommendations. There is no transaction associated with this test step.

No Pre-Condition

The EHR has recorded all of demographic and social history data in the record created for Anita Francesca Marina.

Register New Patients: The EHR or other clinical software system must allow a user to enter distinguishing information about patients so that providers can uniquely identify patients who have similar sounding names or other similar identifying information. For example, twins living in the same household will have similar dates of birth, addresses, and may have similar names. The EHR or other clinical software system must be able to store information to successfully match with patients in immunization registries, if the information is available. Specific to immunization registries, that information includes the mother's maiden name, whether the patient was part of a multiple birth, and the birth order (i.e., ordinal number of birth, first, second, etc.). This information allows the provider to correctly identify the patient and also helps ensure a match when the EHR sends the patient's information to external systems such as an immunization registry.

Evaluation Criteria: Vendor successfully records all demographic data provided, with all required attributes indicated by [Y]. The coded values are not expected to be displayed to the user, but it is expected that the value selected has the identified meaning, and it is expected that the system will use the coded value when the attribute is conveyed in later transactions:

To minimize data entry, the ADT A04 message below the data table may be used to automate data entry. If this option is used, the proctor will review the ability of the system to record, modify, and store these attributes. This ADT message includes clinical content referenced in step 5.

   Social History:

ADT A04 Message:

MSH|^~\&|Test EHR Application|X68||NIST Test Iz Reg|20221031082240-0500|ADT^A04^ADT_A01|NIST-IZ-001.00|P|2.5.1|||||||||

PID|1||123456^^^MYEHR^MR~987633^^^MYIIS^SR||Marina^Anita^Francesca^^^^L|Santos^Sophia^Serena^^^^M|19970601|F||2106-3^White^CDCREC|4623 Standish Way^^Stamford^CT^06903^USA^L||^PRN^CP^^1^203^5551213||eng^English^ISO639|||||||2135-2^Hispanic or Latino^CDCREC||N

PD1|||||||||||02^Reminder/Recall – any method^HL70215|N|20131001|||A|20131001|20131001

NK1|1||EMR^Employer^HL70063^^^^2.5.1|15 State St^^Stamford^CT^06903^^L|||||||||River Rehabilitation Center^L|||||||||||||||||

PV1||O|||||^Jobs^John^^^^^^^L^^^^^^^^^^^MD|^Jobs^John^^^^^^^L^^^^^^^^^^^MD|||||||||||||||||||||||||||||||MPC^Metro Primary Care^HL70362||||||

OBX|1|CE|51913-2^Hepatitis A virus IgG+IgM Ab [Presence] in Serum^LN|1|260373001^Detected^SCT||||||F|||20180515

OBX|2|CE|51914-0^Hepatitis B virus core IgG+IgM Ab [Presence] in Serum^LN|1|260415000^Not Detected^SCT||||||F|||20180515

OBX|3|CWE|21844-6^Usual Industry^LN||621610.008495^Home nursing services (except private practices)^ODH||||||F|||20221031|||||||||||||||

OBX|4|CWE|21843-8^History of Usual Occupation^LN||29-1141.04.000450^Adult Health Clinical Nurse Specialist^ODH||||||F|||20221031|||||||||||||||

DG1|1|||278971009^Hepatitis A immune (finding)^SCT|20180515|F|

DG1|2|||165808001^Hepatitis B non-immune (finding)^SCT|20180515|F|

Publicity Code is included in order to support documentation of communication method for the TestCase: Notify Patients of Immunization Status. If the EHR does not support this attribute, the result for this step may indicate pass, but the lack of support should be documented as a notable exception.

While the PID indicates that it is Vendor Supplied, the ID returned from the registry query is: 123456^^^MYEHR^MR~987633^^^MYIIS^SR. The IIS will not know the PID of the local system, and there is no context-based validation checking for the PID.

Protection Indicator Effective Date may use current date if constrained by EHR workflow.

Document in notable exceptions where any of the social history attributes can not be captured/recorded by product.

The Anita Francesca email supplied should be provided by the test proctor so they can receive the patient notifications. For the purpose of internal Vendor testing they can use their own emails.

Manual entry of one of the patient demographics and clinical history will be required (or reviewed) to ensure that entry of the required fields is possible.

The patient is able to provide information about the influenza vaccine that she received through her employer out of state using the patient facing features (e.g. portal) offered by the EHR.

No Comments

The patient has been provided access to a patient facing mechanism to provide information electronically to the provider regarding her historical immunization record.

The immunization history from the employer as reported by the patient is available for review by the provider through the EHR.

Provide Access to Update Immunization Information: The patient is able to add or request an update to immunization information for review by the provider.

Evaluation Criteria: Vendor successfully captures the historical vaccination information from the patient. The electronic information provided may be supplied by whatever means is offered through the EHR (e.g. email, uploaded pdf, patient entered into a form, etc.).

The information provided by the patient for review by the physician includes:

The EHR may collect the information from the patient through any electronic means. The tester shall document the method used to capture the information.

The patient provided information is not part of the EHR until the provider reviews the information in the next step and accepts/modifies the content.

The provider is able to review the patient provided vaccine information for the influenza vaccine that she received through her employer out of state. The provider is able to document this historical vaccine in the EHR.

No Comments

The patient has been provided access to the patient immunization history record.

The immunization administered through Anita Francesca Marina’s employer, and as reported by the patient is available for review by the provider through the EHR.

The immunization history from patient-provided vaccine history has been reviewed by the provider and is loaded into the record created for Anita Francesca Marina.

Review Patient-Provided Immunization Information: The EHR or other clinical software system provides a mechanism for the provider to review patient-generated immunization data.  It also provides a mechanism for the provider to update or annotate the immunization history, indicating the source of the information.

Record Past Immunizations: The EHR or other clinical software system allows providers to enter information about immunizations given elsewhere (e.g., by another doctor, at a public health clinic, pharmacy, etc.) with incomplete details.

Request/Receive Patient Immunization Data and Identify Source: The EHR stores immunization history accepted electronically from other sources (such as a public health immunization registry consistent with HL7 version 2.5.1, Implementation Guide for Immunization Messaging Release 1.5) or communicated by the patient and manually entered by the clinician. When viewing such information, the provider can determine which immunizations were administered by the practice, which were entered historically as patient-reported, and which were accepted electronically from the public health registry.

Supporting data for:

Compare Public Health Immunization Registry (IIS) Immunization History to EHR Immunization History: The public health immunization registry has returned the requested immunization history for a patient (Return Evaluated Immunization History and Forecast (Z42) – HL7 Version 2.5.1 Implementation Guide for Immunization Messaging Release 1.5). The EHR is able to display the evaluated immunization history received from the registry as well as the immunization history already present in the EHR so that a user can compare them. The EHR provides a way for the provider to view both histories, determine what is different (if anything), and update the existing EHR immunization history with new information from the public health registry if they choose to do so. The system must store the new information as structured data as part of the patient's local immunization history and include the time of the update and the source of the new information.

Evaluation Criteria: Vendor successfully captures the historical vaccination information from the patient that she received through her employer. The electronic information provided may be supplied by whatever means is offered through the EHR (e.g. email, uploaded pdf, patient entered into a form, etc.).

The information provided by the patient for review and recording by the physician includes:

The EHR may collect the information from the patient through any electronic means. The tester shall document the method used to inform the provider of the historical vaccine information and to allow for the provider review.

Lab tests show serologic immunity to Hepatitis A, and no serologic immunity to Hepatitis B. These finding are in the documented in the record created for Anita Francesca Marina indicating that she is Hepatitis A Immune, and that she has no immunity to Hepatitis B.

No Comments

The EHR has recorded the demographic information in the record created for Anita Francesca Marina.

The serologic immunity (Hepatitis A virus IgG+IgM Ab [Presence] in Serum) - result positive and a finding of Hepatitis A Immune is documented in the record for Anita Francesca Marina.

The lack of serologic immunity (Hepatitis B virus IgG+IgM Ab [Presence] in Serum) - result negative and a finding of Hepatitis B non-immunity is documented in the record for Anita Francesca Marina.

Support for:

View Reconciled Immunization Forecast: The EHR or other clinical software system has the ability to re-evaluate and update the immunization forecast using a patient's newly updated immunization history. Forecasts are updated following reconciliation of immunization data contained in the public health immunization registry with immunization data contained in the EHR. Processing the new forecast can be internal to the EHR or it can use an external forecasting service, but should reference the most recent recommendations.

 Note: clinical history for adult healthcare worker supporting vaccine recommendations.

Evaluation Criteria: Vendor successfully records all clinical history data provided. The coded values are not expected to be displayed to the user, but it is expected that the value selected has the identified meaning, and it is expected that the system will use the coded value when the attribute is conveyed in later transactions:

Serologic Evidence of Non-Immunity to Hepatitis B and Serologic evidence of Immunity to Hepatitis A are documented in the record:

Lab Result and Finding (05/15/2018):

LOINC 51913-2 Hepatitis A virus IgG+IgM Ab [Presence] in Serum – result positive

LOINC 51914-0 Hepatitis B virus core IgG+IgM Ab [Presence] in Serum - result negative

Finding of Hepatitis A Immunity is recorded (SNOMED 278971009 Hepatitis A immune (finding))

Finding of Hepatitis B non-immunity is recorded (SNOMED 165808001 Hepatitis B non-immune (finding))

Manual entry of one of the patient demographics and clinical history will be required (or reviewed) to ensure that entry of the required fields is possible.

The provider enters vaccine inventory data from available inventory.

2D barcodes are provided as an option to enter the inventory.

No Pre-Condition

Vaccine inventory is recorded and available in the EHR.

Update Vaccine Inventory from Stock Receipt: The EHR or other clinical software system updates the vaccine inventory when new stock is received at the site and updates the correct count of each vaccine, including those for use in guarantee programs (such as Vaccines for Children) and for private stock.

Display Available Vaccine Antigens: The system presents a list of vaccine antigens available for administration to patients (i.e., private stock vs. specific guarantee program).

Evaluation criteria is defined within each test step.

Vendors are encouraged to scan the 2D barcode images as data input. If vendors use a 2D barcode scanner it is expected that at least one vaccine product into the system’s inventory. Tester should document feedback and any identified issues with 2D barcode images.

The provider receives a vaccine delivery and records the new vaccine data in available inventory.

Set-up step evaluating EHR functions for capturing and storing vaccine inventory data.

No Pre-Condition

Vaccine inventory is recorded and available in the EHR.

Update Vaccine Inventory from Stock Receipt: The EHR or other clinical software system updates the vaccine inventory when new stock is received at the site and updates the correct count of each vaccine, including those for use in guarantee programs (such as Vaccines for Children) and for private stock.

Vendor successfully records all vaccine inventory data provided:

Item 1
	Use (Vial or Syringe)
Labeler:	GlaxoSmithKline Biologicals SA
NDC:	58160-0890-41
Product Name:	FLUARIX QUADRIVALENT
Lot#:	8L4B3521
Expiration Date:	12/31/2023
GTIN:	10358160890410
Vaccine source:	VFC
Quantity:	12
Presentation:	Prefilled syringe (PFS)
2D Barcode:
Item 2
	Use (Vial or Syringe)
Labeler:	GlaxoSmithKline Biologicals SA
NDC:	58160-0890-41
Product Name:	FLUARIX QUADRIVALENT
Lot#:	D8043IN8422
Expiration Date:	12/31/2023
GTIN:	10358160890410
Vaccine source:	VFC
Quantity:	15
Presentation:	Prefilled syringe (PFS)
2D Barcode:
Item 3
	Use (Vial or Syringe)
Labeler:	GlaxoSmithKline Biologicals SA
NDC:	58160-0890-41
Product Name:	FLUARIX QUADRIVALENT
Lot#:	D8043IN8855
Expiration Date:	12/31/2023
GTIN:	10358160890410
Vaccine source:	VFC
Quantity:	12
Presentation:	Prefilled syringe (PFS)
2D Barcode:
Item 4
	Use (Vial or Syringe)
Labeler:	GlaxoSmithKline Biologicals SA
NDC:	58160-0820-43
Product Name:	ENGERIX-B
Lot#:	6332FK18
Expiration Date:	06/15/2022
GTIN:	10358160820431
Vaccine source:	Non-VFC
Quantity:	18
Presentation:	Prefilled syringe (PFS)
2D Barcode:
Item 5
	Use (Vial or Syringe)
Labeler:	GlaxoSmithKline Biologicals SA
NDC:	58160-0820-43
Product Name:	ENGERIX-B
Lot#:	6332FK26
Expiration Date:	12/31/2023
GTIN:	10358160820431
Vaccine source:	Non-VFC
Quantity:	20
Presentation:	Prefilled syringe (PFS)
2D Barcode:
Item 6
	Use (Vial or Syringe)
Labeler:
NDC:	58160-0811-43
Product Name:	Pediarix
Lot#:	6559FK32
Expiration Date:	12/31/2023
GTIN:	10358160811439
Vaccine source:	Non-VFC
Quantity:	16
Presentation:	Prefilled syringe (PFS)
2D Barcode:
Item 7
	Use (Vial or Syringe)
Labeler:	Pfizer Manufacturing Belgium NV
NDC:	59267-1000-01
Product Name:	Pfizer-BioNTech Covid-19 Vaccine
Lot#:	8L7B3418
Expiration Date	12/31/2023
GTIN:	00359267100016 (see notes)
Vaccine source:	Non-VFC
Quantity (doses):	450
Presentation:	Multi-use vials
2D Barcode:	See Notes
Item 8
	Use (Vial or Syringe)
Labeler:	GlaxoSmithKline Biologicals SA
NDC:	58160-0821-05
Product Name:	ENGERIX-B (adult)
Lot#:	6942FL12
Expiration Date:	12/31/2023
GTIN:	10358160821056
Vaccine source:	Non-VFC
Quantity:	16
Presentation:	Prefilled syringe (PFS)
2D Barcode:

Vendors are encouraged to scan the 2D Barcode images as data input. Tester should document feedback and any identified issues with 2D Barcode images. 

A GTIN for Pfizer-BioNTech COVID-19 Vaccine (PURPLE CAP) (NDC: NDC 59267-1000-01) had not yet been assigned at the time this test plan was generated. A GTIN was generated for the purpose of this test according to GS1 standards and may be updated in the future should this be changed in IIS: NDC Lookup Crosswalk published by CDC. The lack of an assigned GTIN also means a GS1 DataMatrix (2D barcode) was not created for this test plan. Vendors must therefore hand enter this vaccine information.

Because the influenza season may not align with the test plan execution, the most current influenza vaccine may not be present.

The new vaccine information needs to be added before inventory can be added for a specific vaccine.

The provider reviews the full list of vaccine inventory.

No Comments

Inventory has been entered into the EHR.

The list of available inventory is displayed.

Display Available Vaccine Antigens: The system presents a list of vaccine antigens available for administration to patients (i.e., private stock vs. specific guarantee program).

The EHR inventory shows (minimally):

Item 1
	Use (Vial or Syringe)
Labeler:	GlaxoSmithKline Biologicals SA
NDC:	58160-0890-41
Product Name:	FLUARIX QUADRIVALENT
Lot#:	8L4B3521
Expiration Date:	12/31/2023
GTIN:	10358160890410
Vaccine source:	VFC
Quantity:	12
Presentation:	Prefilled syringe (PFS)
2D Barcode:
Item 2
	Use (Vial or Syringe)
Labeler:	GlaxoSmithKline Biologicals SA
NDC:	58160-0890-41
Product Name:	FLUARIX QUADRIVALENT
Lot#:	D8043IN8422
Expiration Date:	12/31/2023
GTIN:	10358160890410
Vaccine source:	VFC
Quantity:	15
Presentation:	Prefilled syringe (PFS)
2D Barcode:
Item 3
	Use (Vial or Syringe)
Labeler:	GlaxoSmithKline Biologicals SA
NDC:	58160-0890-41
Product Name:	FLUARIX QUADRIVALENT
Lot#:	D8043IN8855
Expiration Date:	12/31/2023
GTIN:	10358160890410
Vaccine source:	VFC
Quantity:	12
Presentation:	Prefilled syringe (PFS)
2D Barcode:
Item 4
	Use (Vial or Syringe)
Labeler:	GlaxoSmithKline Biologicals SA
NDC:	58160-0820-43
Product Name:	ENGERIX-B
Lot#:	6332FK18
Expiration Date:	06/15/2022
GTIN:	10358160820431
Vaccine source:	Non-VFC
Quantity:	18
Presentation:	Prefilled syringe (PFS)
2D Barcode:
Item 5
	Use (Vial or Syringe)
Labeler:	GlaxoSmithKline Biologicals SA
NDC:	58160-0820-43
Product Name:	ENGERIX-B
Lot#:	6332FK26
Expiration Date:	12/31/2023
GTIN:	10358160820431
Vaccine source:	Non-VFC
Quantity:	20
Presentation:	Prefilled syringe (PFS)
2D Barcode:
Item 6
	Use (Vial or Syringe)
Labeler:
NDC:	58160-0811-43
Product Name:	Pediarix
Lot#:	6559FK32
Expiration Date:	12/31/2023
GTIN:	10358160811439
Vaccine source:	Non-VFC
Quantity:	16
Presentation:	Prefilled syringe (PFS)
2D Barcode:
Item 7
	Use (Vial or Syringe)
Labeler:	Pfizer Manufacturing Belgium NV
NDC:	59267-1000-01
Product Name:	Pfizer-BioNTech Covid-19 Vaccine
Lot#:	8L7B3418
Expiration Date	12/31/2023
GTIN:	00359267100016 (See Notes)
Vaccine source:	Non-VFC
Quantity (doses):	450
Presentation:	Multi-use vials
2D Barcode:	See Notes
Item 8
	Use (Vial or Syringe)
Labeler:	GlaxoSmithKline Biologicals SA
NDC:	58160-0821-05
Product Name:	ENGERIX-B (adult)
Lot#:	6942FL12
Expiration Date:	12/31/2023
GTIN:	10358160821056
Vaccine source:	Non-VFC
Quantity:	16
Presentation:	Prefilled syringe (PFS)
2D Barcode:

Tester should document how quantity is displayed and what is present (e.g. volume, # doses).

Because the influenza season may not align with the test plan execution, the most current influenza vaccine may not be present.

A GTIN for Pfizer-BioNTech COVID-19 Vaccine (PURPLE CAP) (NDC: NDC 59267-1000-01) had not yet been assigned at the time this test plan was generated. A GTIN was generated for the purpose of this test according to GS1 standards and may be updated in the future should this be changed in IIS: NDC Lookup Crosswalk published by CDC. The lack of an assigned GTIN also means a GS1 DataMatrix (2D barcode) was not created for this test plan. Vendors must therefore hand enter this vaccine information.

The user responsible for the EHR configuration updates the system with new vaccine codes, new vaccine schedules, and establishes SOAP-bases CDC WSDL configuration.

No Comments

The EHR configuration needs updating.

The codes for the new vaccine are available in the EHR to document the administration of a new vaccine product. The vaccine recommendation is updated for this new vaccine, and the EHR is configured to use the SOAP-based CDC WSDL for communications with an IIS.

Add new vaccine codes:  Add codes to support new vaccines. This includes vaccine codes (CVX), National Drug Codes (NDC), and Vaccine Information Statement codes (VIS).

Update Patient Immunization Schedule: The EHR or other clinical software system displays a patient’s anticipated immunization schedule routinely and updates the patient’s schedule when immunization guidelines change.

Configure SOAP-based CDC WSDL for Transport: The EHR or other clinical software system configures connectivity using the SOAP-based CDC WSDL and demonstrates compliance with this standard transport

Add Jurisdiction-Specific Vaccine Eligibility Code: The EHR or other clinical software system demonstrates the ability to configure dose level vaccine eligibility codes per jurisdictional requirements. This includes tracking and exchanging a jurisdiction-specific dose level eligibility code for administered vaccines. Note that this capability only applies to newly administered doses, not historical doses.

Evaluation criteria is defined within each test step.

None

The user responsible for the EHR configuration updates the system with new CVX, NDC, and VIS vaccine codes.

No Comments

The EHR configuration needs updating with new vaccine information.

The CVX, NDC, and VIS codes for the new vaccine is available in the EHR to document the administration of this new product.

Add new vaccine codes: Add codes to support new vaccines. This includes vaccine codes (CVX), National Drug Codes (NDC), and Vaccine Information Statement codes (VIS).

The EHR vendor demonstrates the mechanism to add the following new vaccine information:

These codes will be used to administer the new vaccine in later test steps. 

It is acceptable to demonstrate without saving the information, and a substitute vaccine will be used later in the testing.

Should additional content be needed to complete the new record, the vendor may supply this detail, and the tester will document such information to inform future updates.

The vendor may need to show the screens and omit the commit action. If so, a substitute vaccine may be leveraged for later steps.

 The tester shall document any additional comments or concerns identified by the vendor.

The new vaccine information needs to be added before inventory can be added for a specific vaccine.

The user responsible for the EHR configuration updates the system with a new vaccine schedule

No Comments

The EHR needs to be updated with a new immunization schedule for a vaccine product.

The updated Patient Immunization Schedule for the vaccine product is available.

Update Patient Immunization Schedule: The EHR or other clinical software system displays a patient’s anticipated immunization schedule routinely and updates the patient’s schedule when immunization guidelines change.

The EHR is able to update the patient immunization schedule for the following adult vaccine:

The vendor may leverage an external tool to support vaccine schedule information. If so, the vendor should provide documentation regarding how the schedule is updated, how the EHR vendor and providers are notified of the updated schedule, and where in the EHR the modification has impact.

These codes will be used to administer the new vaccine in later test steps. 

It is acceptable to demonstrate without saving the information, and a substitute vaccine will be used later in the testing.

Should additional content be needed to complete the new record, the vendor may supply this detail, and the tester will document such information to inform future updates.

The vendor may need to show the screens and omit the commit action. If so, a substitute vaccine may be leveraged for later steps.

The tester shall document any additional comments or concerns identified by the vendor.

The test is the ability to enter the schedule and it may not reflect the current COVID schedule.

The user responsible for the EHR configuration establishes SOAP-based CDC WSDL configuration and successfully submits a VXU record.

No Comments

The EHR is ready to be configured to established connectivity with an IIS.

Transport is configured to use the SOAP-based CDC WSDL.

Configure SOAP-based CDC WSDL for Transport: The EHR or other clinical software system configures connectivity using the SOAP-based CDC WSDL and demonstrates compliance with this standard transport.

Using the test tool and instructions published by NIST at:

 https://hl7v2-iz-cdc-testing.nist.gov/iztool/#/soapConn

 the EHR or other clinical software system is able to successfully execute both Sender (Initiator) test cases:

• Test Case: SOAPCON_1_BasicMessage_ConnectivityRequest
• Test Case: SOAPCON_3_SubmitSingleMessage_Message

All instructions and test details are available at https://hl7v2-iz-cdc-testing.nist.gov/iztool/#/soapConn

The tester shall document any additional comments or concerns identified by the vendor.

The user responsible for the EHR configuration adds a list of jurisdiction dose level vaccine eligibility codes that reflect jurisdiction-funded vaccine campaigns.

No Comments

The EHR is ready to be configured to established connectivity with an IIS that uses jurisdiction dose level vaccine eligibility codes for jurisdiction-funded vaccine campaigns.

Jurisdiction dose level vaccine eligibility codes are configured and available for recording during vaccine administration.

Add Jurisdiction-Specific Vaccine Eligibility Code: The EHR or other clinical software system demonstrates the ability to configure dose level vaccine eligibility codes per jurisdictional requirements. This includes tracking and exchanging a jurisdiction-specific dose level eligibility code for administered vaccines. Note that this capability only applies to newly administered doses, not historical doses.

The EHR or other clinical software system demonstrates the addition of the following jurisdiction dose level vaccine eligibility codes:

For 2021/2022 HIMSS IIP test evaluation, this capability is introduced as a ‘Discovery’ requirement. Developers will be requested to walk through desktop testing to identify current or prospective approaches. They will demonstrate the capability if the functionality exists.  The HIMSS IIP observer will record the process to evaluate whether this capability should be included in future testing.

Juana Mariana Vazquez visits the provider where her immunization history is retrieved from the registry and reconciled with the local information in the medical record to determine vaccines that are due. Vaccinations are ordered and administered. The parents refuse the Polio vaccine due to prior issues. The vaccines are reported to the immunization registry and a vaccine summary is available for the patient.

The EHR generates a Z44 query to the Immunization Registry to retrieve the Evaluated History and Forecast for Juana Mariana Vazquez.

Querying the registry will consist of the vendor creating Z44 messages for Juana Mariana Vazquez to be sent to the registry. The response will be processed as part of the 'Display, Reconcile, Import and Update Immunization Information' activity.

Using the Z42 Response to Immunization Registry Query, the EHR displays the Evaluated History and Forecast to the user for reconciliation and update. The vendor will receive information back from the registry and show the ability to view and reconcile, and import the information returned by the registry (NOTE: the Z42 message will be provided either manually, or as part of the tool). This test will also look at the system's ability to view the forecast returned by the registry and create a new forecast after reconciling the information.

No Comments

Juana Mariana Vazquez is entered as a patient in the EHR with complete Demographic data, Immunization History Data, and Clinical Data according to the steps in the 'Juana Mariana Vazquez Initial Data Load.'

A Z44 Query is generated and submitted to the Immunization Registry/Test tool, and a Z42 response is returned.

Select New Patient: The EHR or other clinical software system must allow a user to distinguish information about patients with similar names or identifying information in order to select the right patient from the providers’ EHR or other clinical software system. This information is crucial for identifying and selecting the correct patient.  For example, twins living in the same household will have similar dates of birth, addresses, and may have similar sounding names. In order to match patients with those already in the immunization registry, the EHR or other clinical software should have the ability to record the mother’s maiden name, whether the patient was part of a multiple birth, and if so, the order of birth (when such information is available). The provider should be aware of how often the protection indicator information must be updated based on local rules.

Request/Receipt of Patient Immunization History: The EHR or other clinical software system sends a request to the public health immunization registry "on demand," or in advance for those with scheduled appointments. The request includes the identifying information the immunization registry needs to match each patient with those in the registry including, if present, the mother's maiden name, a multiple birth indicator, and the birth order. The request also is sent in a pre-determined format the registry can read and interpret (Request Evaluated Immunization History and Forecast (Z44) - HL7 version 2.5.1 Implementation Guide for Immunization Messaging Release 1.5).

Compare Public Health Immunization Registry (IIS) Immunization History to EHR Immunization History: The public health immunization registry has returned the requested immunization history for a patient (Return Evaluated Immunization History and Forecast (Z42) – HL7 Version 2.5.1 Implementation Guide for Immunization Messaging Release 1.5). The EHR is able to display the evaluated immunization history received from the registry as well as the immunization history already present in the EHR so that a user can compare them. The EHR provides a way for the provider to view both histories, determine what is different (if anything), and update the existing EHR immunization history with new information from the public health registry if he or she chooses to do so. The system must store the new information as structured data as part of the patient's local immunization history and include the time of the update and the source of the new information.

Request/Receive Patient Immunization Data and Identify Source: The EHR stores immunization history accepted electronically from other sources (such as a public health immunization registry consistent with HL7 version 2.5.1, Implementation Guide for Immunization Messaging Release 1.5) or communicated by the patient and manually entered by the clinician. When viewing such information, the provider can determine which immunizations were administered by the practice, which were entered historically as patient-reported, and which were accepted electronically from the public health registry.

View Immunization Forecast: The EHR or other clinical software system provides a view of the immunization forecast provided by the IIS. The display includes the recommended vaccines and their associated dates (e.g., earliest, recommended, past due, latest) for each vaccine included in the forecast.

View Reconciled Immunization Forecast: The EHR or other clinical software system has the ability to re-evaluate and update the immunization forecast using a patient's newly updated immunization history. Forecasts are updated following reconciliation of immunization data contained in the public health immunization registry with immunization data contained in the EHR. Processing the new forecast can be internal to the EHR or it can use an external forecasting service, but should reference the most recent recommendations.

 Review Patient Immunization History: The EHR or other clinical software systems displays vaccine history by vaccine series.

Record Past Immunizations: The EHR or other clinical software system allows providers to enter information about immunizations given elsewhere (e.g., by another doctor, at a public health clinic, pharmacy, etc.) with incomplete details.

Support for:

Receive Dose Not Indicated Alert for Single Vaccine Order: The EHR or other clinical software system notifies the provider in instances when there are single or combination vaccine orders that are inconsistent with the expected timing intervals included in the vaccine forecast. Inconsistencies include suggestion of different date(s) for ordering the vaccine(s) or indication the vaccine(s) is/are no longer required.

Evaluation criteria is defined within each test step.

No Note

Juana Mariana Vazquez is selected as the patient and her record is opened in the EHR.

No Comments

Juana Mariana Vazquez Initial Data Load completed.

Juana Mariana Vazquez is the active working patient in the EHR.

Select New Patient: The EHR or other clinical software system must allow a user to distinguish information about patients with similar names or identifying information in order to select the right patient from the providers’ EHR or other clinical software system. This information is crucial for identifying and selecting the correct patient. For example, twins living in the same household will have similar dates of birth, addresses, and may have similar sounding names. In order to match patients with those already in the immunization registry, the EHR or other clinical software should have the ability to record the mother’s maiden name, whether the patient was part of a multiple birth, and if so, the order of birth (when such information is available). The provider should be aware of how often the protection indicator information must be updated based on local rules.

Tester shall verify that the product can distinguish Juana Mariana Vazquez from similar sounding names using all of the pediatric demographics. Tester verifies that the product can select the correct patient. The following subset of the patient demographic attributes entered during the initial data load are verified to assure that the correct patient is selected:

No Note

The provider uses the EHR to query the Immunization Registry for an Evaluated History and Forecast based on information known to the Immunization Registry.

No Comments

Juana Mariana Vazquez Initial Data Load is completed.

Juana Mariana Vazquez is the active working patient in the EHR.

The Immunization Registry responds with Evaluated Vaccine History and Forecast for Juana Mariana Vazquez.

Request/Receipt of Patient Immunization History:  The EHR or other clinical software system sends a request to the public health immunization registry "on demand," or in advance for those with scheduled appointments. The request includes the identifying information the immunization registry needs to match each patient with those in the registry including, if present, the mother's maiden name, a multiple birth indicator, and the birth order. The request also is sent in a pre-determined format the registry can read and interpret (Request Evaluated Immunization History and Forecast (Z44)  - HL7 version 2.5.1 Implementation Guide for Immunization Messaging Release 1.5).

Support for:

Receive Dose Not Indicated Alert for Single Vaccine Order: The EHR or other clinical software system notifies the provider in instances when there are single or combination vaccine orders that are inconsistent with the expected timing intervals included in the vaccine forecast. Inconsistencies include suggestion of different date(s) for ordering the vaccine(s) or indication the vaccine(s) is/are no longer required.

Tester shall verify that the vendor can produce a valid Z44 query in accordance with the test data correctly and without omission.

Tester shall verify that the data in the message corresponds to the data in the EHR and contains all test data attributes supplied.

No Note

The Immunization Registry returns an Evaluated History and Forecast (Z42) to the EHR in response to the query for patient (Juana Mariana Vazquez). The provider reviews the immunization history from the registry and compares to the immunization history in the EHR. The provider reviews the information from these sources, identifying information known only to the registry, and identifying information that is more accurately reflected in the local EHR:

The physician accesses the record for Juana Mariana Vazquez and the EHR differentiates:

The following vaccinations are available only to the EHR:

The EHR differentiates the following vaccinations which differ between the EHR and the IIS:

The EHR differentiates the following vaccinations that are available from both the IIS that and the local EHR:

The EHR differentiates the following vaccinations that are available from the IIS that are not known to the local EHR:

No Comments

Juana Mariana Vazquez Initial Data Load is completed.

Juana Mariana Vazquez is the active working patient in the EHR.

A Z44 query has been submitted to the Immunization Registry and a Z42 response is provided back to the EHR.

Evaluated Immunization History returned from the registry is reviewed and compared to the immunizations in the patient record (Juana Mariana Vazquez).

Request/Receive Patient Immunization Data and Identify Source: The EHR stores immunization history accepted electronically from other sources (such as a public health immunization registry consistent with HL7 Version 2.5.1, Implementation Guide for Immunization Messaging Release 1.5) or communicated by the patient and manually entered by the clinician. When viewing such information, the provider can determine which immunizations were administered by the practice, which were entered historically as patient-reported, and which were accepted electronically from the public health registry.

Compare Public Health Immunization Registry (IIS) Immunization History to EHR Immunization History: The public health immunization registry has returned the requested immunization history for a patient (Return Evaluated Immunization History and Forecast (Z42) – HL7 Version 2.5.1 Implementation Guide for Immunization Messaging Release 1.5). The EHR is able to display the evaluated immunization history received from the registry as well as the immunization history already present in the EHR so that a user can compare them. The EHR provides a way for the provider to view both histories, determine what is different (if anything), and update the existing EHR immunization history with new information from the public health registry if they choose to do so. The system must store the new information as structured data as part of the patient's local immunization history and include the time of the update and the source of the new information.

Review Patient Immunization History: The EHR or other clinical software system displays vaccine history by vaccine series.

Support for:

Receive Dose Not Indicated Alert for Single Vaccine Order: The EHR or other clinical software system notifies the provider in instances when there are single or combination vaccine orders that are inconsistent with the expected timing intervals included in the vaccine forecast. Inconsistencies include suggestion of different date(s) for ordering the vaccine(s) or indication the vaccine(s) is/are no longer required.

1. The EHR is able to receive the response from the Immunization Registry.

2. The EHR displays the information returned from the Immunization Registry according to the Juror Document.

- Complete review for Polio administered 3/23/2018, MMR 8/22/2018.

- remaining vaccines may be reviewed only for the vaccine name and date administered.

3. The EHR is able to differentiate the vaccines in the comparison between the EHR and the vaccination history.

The juror document also contains the verification content for the immunization forecast, which is tested and graded separately at step 5: View the vaccination history for Juana Mariana Vazquez. The criteria for this step is tested separately here and graded only with respect to the vaccine history.

The EHR must minimally display the vaccine administered and the date of the immunization.